Magnesium Sulfate Injection Recalled Due to Sterility Assurance Concerns
Specialty Medicine Compounding Pharmacy is recalling Magnesium Sulfate injections because sterility cannot be assured after a related product was found non-sterile.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility for a parenteral drug, which poses a significant risk of serious health consequences such as infection.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Magnesium Sulfate, 1 gm/50 mL and 2 gm/50 mL, prescription-only sterile compounded products. The recall covers 19,200 mL of product manufactured and distributed between July 1, 2013, and October 19, 2013.
The recall was initiated because the affected products were compounded in the same environment and under the same practices as another product that was found to be non-sterile. Consequently, the sterility of the recalled Magnesium Sulfate products cannot be assured. The FDA has classified this recall as Class II.
The affected products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only. Patients and healthcare providers should stop using the recalled products and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s: 07312013@41
- 07312013@42
- 07312013@43
- 07312013@44
- 07312013@45
- 08012013@1
- 08012013@2
- 08012013@4
- 08012013@6
- 08012013@11
- 08012013@3
- 08012013@5
- 08012013@7
- 08012013@8
- 08012013@9
- 08012013@10
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Specialty Medicine Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 51 products in this recall →Related recalls
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